61 computer system validation jobs at 49 companies in Lynn, MA
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Principal Computer System Validation Specialist
Westborough, Massachusetts, United States
$105k-$150k/yrHybridFull Time
Astellas PharmaTokyo Stock Exchange: 4503: Global developing and manufacturing pharmaceutical therapies for patients.
5+ YOEBachelor's degree, 5–8 years computer system validation in pharma/biotech, deep knowledge of GxP/GAMP 5/21 CFR Part 11/Annex 11, experience validating LIMS/MES/QMS/ERP/OSI PI/Empower/SAP/LabWare, strong technical writing and project management.
LIMS, MES, QMS, ERP, OSI PI, Empower, SAP, LabWare, GAMP 5, 21 CFR Part 11, EU Annex 11
Computer System Validation - Senior Consultant - Life Sciences
New York or Boston or Chicago or Hoboken or McLean or Pittsburgh or Philadelphia or Washington
$94k-$155k/yrHybridFull Time
EY: Global firm providing audit, tax, and professional consulting services.
3+ YOEBachelor's degree in a technical field and 3+ years life sciences validation experience; strong CSV, SDLC/Agile, GxP/regulatory and risk-based validation knowledge.
Senior Quality Engineer, Computer System Validation (CSV)
Northbridge or Watertown
$142k-$179k/yrHybridFull Time
EyePoint PharmaceuticalsNASDAQ: EYPT: Clinical-stage developing sustained-delivery treatments for retinal diseases.
3+ YOEBachelor's degree and 3+ years GxP computerized system validation experience in pharma/biotech/medical device; knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9/Q10 and FDA CSA; strong documentation, risk management, and project leadership skills.
GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9, ICH Q10, FDA Computer Software Assurance (CSA), RCA, FMEA, VSM, ERP
LonzaSIX Swiss Exchange: LONN: Manufactures medicines and provides development services for healthcare companies.
5+ YOEBachelor's degree required (CS/engineering/sciences preferred); 5+ years CSV experience; 2+ years with controls/automation, MES or Distributed Systems; biotech/pharma/medical device experience; CAPA/deviation and project experience desired.
DeltaV, Manufacturing Execution Systems (MES), GAMP
Group 1 AutomotiveNYSE: GPI: Automotive retailer operating dealerships, collision centers, and service departments.
2+ YOETwo or more years in automotive parts; high school diploma; valid driver's license; strong customer service; ability to price parts and use computer systems.
RoslinCT: Contract manufacturing for advanced cell and gene therapies.
8+ YOE8+ years QA experience in pharma/biotech GMP environment, 3+ years software validation QA, knowledge of Computer System Validation, GAMP, 21 CFR Part 11 and Annex 11, ability to support audits and drive quality systems improvements.
GAMP, Computer System Validation (CSV), 21 CFR Part 11, Annex 11
Tractor Supply CompanyNASDAQ: TSCO: Rural lifestyle retail chain for agricultural and pet supplies.
Prior retail or merchandising experience required; must be 18+, valid driver’s license, able to lift up to 50 lbs, operate store equipment, perform physical tasks, and use basic computer systems.
ArdelyxNASDAQ: ARDX: Discovers and develops medicines for unmet medical needs.
8+ YOEBachelor's degree and 8+ years CV or related life sciences experience; expertise in computer systems validation, risk-based validation, GxP/FDA regulations, SDLC, test management, and cross-functional coordination.
test management tools, virtualization, directory services, storage, DBMS
Lexington Public Schools: Providing K-12 public education to students in Lexington, Massachusetts.
8+ YOEMassachusetts Master electrician license, valid driver’s license, HS diploma or equivalent, 8+ years electrical trade experience, proficiency with diagnostics and building systems, basic computer skills, ability to lift 50 lbs and work in varied environments.
MCPHS: Private university providing healthcare and life sciences education.
High school diploma or GED, valid driver’s license, basic knowledge of building systems (HVAC, Plumbing, Electrical), basic carpentry, hand tools, basic computer skills, ability to multitask, English reading/writing, ability to work off-hours/weekends.
HVAC systems, Plumbing, Electrical systems, Carpentry tools, Hand tools, Computer
Green Thumb IndustriesCanadian Securities Exchange: GTII: Produces and distributes cannabis consumer packaged goods and retail services.
1+ YOE1+ year customer service experience; must be 21+; valid driver’s license or state ID; pass state cannabis background checks; ability to lift up to 30 lb, operate POS/computer systems, and work varied shifts including weekends and nights.
POS, computer, word processing, database management, spreadsheet applications, email
Harr Motor Group: Selling and servicing new and used motor vehicles.
2+ YOECustomer-service experience (automotive preferred), strong communication and organizational skills, proficiency with computer systems, valid driver’s license, ability to stand and work around vehicles.
Valid driver's license, excellent customer service and communication skills, ability to multitask, basic automotive knowledge, ability to perform light physical tasks and use dealership computer systems.
McGovern Automotive Group: Automotive dealer group operating new and used vehicle dealerships.
Provide diesel and automotive service including engine analysis, diagnostics, suspension, brakes, and computer-controlled systems; must have valid driver's license and ability to communicate and work in a team.
Asbury Automotive GroupNYSE: ABG: Operates franchised car dealerships and provides vehicle maintenance services.
Experience as service advisor preferred; valid driver's license; must be 18+; excellent customer service and communication; ability to pass background and drug tests; proficient with computers and phone systems.
City of Nashua: Providing municipal governance and public services for Nashua residents.
Professional experience in law enforcement or related field; knowledge of recruiting and interviewing techniques; ability to use department computer systems; valid driver's license; experience with outreach, testing administration, and background investigations.
Sanel NAPA: Distributes and sells automotive and heavy-duty truck parts.
Valid driver’s license with clean record, 18+, high school diploma/GED, ability to lift up to 60 lbs, comfortable with basic computer/tablet systems, reliable and customer-service oriented.
Summit Companies: Provides fire protection and life safety services.
3+ YOEHS diploma, current fire sprinkler license, valid driver's license, 3+ years installing pipe systems and valves, ability to read blueprints, operate computer/tablet, troubleshoot, and train apprentices.